Reported Nov 30, 2016 · Terminated
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System
- Lot codes and dates
- Device Listing NumberD011448 (Kc110)
- and D244577 (KC110B) Lot numbersMGM081 and MGM082
- Amount recalled
- 9,935 units
Where it was sold
- Nationwide
Why it was recalled
Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.
This product could cause temporary or reversible health problems — stop using it.
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